MYGN - NASDAQ

Good day, and thank you for standing by. Welcome to the Myriad Genetics Second Quarter 2025 Financial Earnings Conference Call. [Operator Instructions] Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, Matt Scalo. Please go ahead.

Good afternoon, and welcome to the Myriad Genetics Second Quarter 2025 Earnings Call. During the call, we will review the financial results we released today. And afterwards, we will host a Q&A session. Our quarterly earnings release was issued this afternoon on Form 8-K and can be found on our website at investor.myriad.com. I'm Matt Scalo, Senior Vice President of Investor Relations, and on the call with me today are Sam Raha, our President and Chief Executive Officer; Scott Leffler, our Chief Financial Officer; and Mark Verratti, our Chief Operating Officer. This call can be heard live via webcast at investor.myriad.com, and a recording will be archived in our Investors section of our website, along with the slide presentation. Please note that some of the information presented today contains projections or other forward-looking statements regarding future events or the future financial performance of the company. These statements are based on management's current expectations, and the actual events or results may differ materially and adversely from these expectations for a variety of reasons. We refer you to the documents the company files from time to time with the SEC, specifically the company's annual report on Form 10-K, its quarterly reports on Form 10-Q and its current reports on Form 8-K. These documents identify important risk factors that could cause the actual results to differ materially from those contained in our projections or forward-looking statements. With that, I'll now turn the call over to Sam.

Thanks, Matt. Good afternoon, everyone, and thank you for joining us. Before I begin, I want to share that I believe today, as I did when I joined the company, that Myriad is really good at a lot of things and we have significant potential, but we have not lived up to our potential yet. I'm excited about the journey we're on to live up to that potential by focusing on high-growth market segments and executing with stepped-up urgency and strengthened execution rigor. Let me start with our results. I'm pleased to report on the overall progress the team has made, both financially and operationally in the second quarter. We generated revenue of $213 million, representing an increase of 5% year-over-year when you exclude UnitedHealthcare's decision on GeneSight and the divested European EndoPredict business. Growth in average revenue per test during the second quarter, up 2% year-over-year with growth across most of our tests year-over- year was a leading contributor to our strong Q2 results. This growth in underlying average revenue per test has been enabled by great execution in Q2 and over many quarters on multiple programs that are part of our pricing improvement operational plan by our strong revenue cycle team. There are no material revenue contributions from prior periods. This momentum certainly provides a nice tailwind in the second half of the year and supports our profitable growth journey. Our strong results were also enabled by the actions we have been taking to address the challenges we noted on our Q1 call. I'm pleased that our execution has been better and quicker, contributing to our better-than-projected revenue growth, a step forward on delivering on Myriad's potential. Now I want to talk about testing volume. We continue to have strong volume growth for MyRisk HCT in oncology at 14% over the year ago quarter. We saw a return to volume growth from MyRisk HCT for unaffected as our efforts on addressing previously identified challenges with customer workflows, including EMR functionality, are starting to be addressed, which Mark will talk about further in his section. GeneSight volume increased from low single digits to 5% growth year-over-year as we had anticipated based on our organization settling in after deliberate cost savings related actions we made in Q1 and our focus on targeted accounts. Prolaris volume, as we anticipated, was slightly down year-over-year against a strong Q2 of 2024 compare but up 6% sequentially over Q1 of 2025. Volume for our legacy prenatal products, Prequel and Foresight, declined 7% year-on-year. This was based on challenges we had with implementing an order management system, which slowed down orders in Q2. I've been close to this, working with our CTO, Kevin Hass, Mark Verratti and our Chief Commercial Officer, Brian Donnelly. We have fixed the prenatal ordering system issue. There's no remaining impact to customers, and we expect to see improving trends in prenatal volume growth starting in Q3. Along with maintaining strong growth for hereditary cancer testing in oncology, mid-single-digit growth for GeneSight and resuming growth for our prenatal products, we are actively executing programs to increase growth for HCT and unaffected and Polaris. We believe these actions will lead to increasing volume growth in Q3 and Q4 and enable us to enter 2026 with momentum. Turning now to profitability. We generated strong adjusted gross margin, 71.5% in the second quarter or 140 basis points greater than last year and closely managed our discretionary spend as reflected in our adjusted OpEx line, ultimately reported strong adjusted EBITDA of $14.5 million or 24% growth over last year and $0.05 of adjusted EPS for the second quarter. I'm pleased that Myriad secured a $200 million term loan from OrbiMed, a well-known investor in the health care industry. We ran a thorough process working with Evercore and we're very happy with the number and quality of interested lenders. We're excited to partner with OrbiMed on the credit facility, which provides us with liquidity and flexibility to support our growth journey. The journey ahead will be enabled by our updated strategy intended to drive accelerated growth and profitability by focusing on the Cancer Care Continuum as we will refer to it as the CCC. Before I share more about our strategy, let me note that based on our Q2 results and the progress we're making on addressing identified challenge, we are raising guidance for 2025. Scott will share more details in his section. Now on the next slide, I want to provide a summary of our updated strategy. Since becoming CEO, one of my top priorities has been to work on updating our long-range strategy to provide clarity on our direction for this next chapter of Myriad. Since May, we made significant progress on advancing our strategy work. While next-level details will be completed over the coming months, the core of our updated strategy is to drive accelerated growth and profitability by focusing on the Cancer Care Continuum. There are 3 strategic pillars to support its achievement. On the next slide, let me start by answering the question, why focus on cancer? After careful consideration of different possibility, we're choosing to focus on the Cancer Care Continuum for a number of reasons. The cancer-related market is sizable and growing with good reimbursement. We are a pioneer in cancer diagnostics and have a strong reputation for high-quality products established over 30 years. We have market-leading products for HCT and HRD, and we have extensive commercial coverage with health care providers and systems. Now let me walk you through our first pillar, focusing on the Cancer Care Continuum to accelerate growth. We will leverage our leadership in hereditary cancer testing and increased growth with initiatives such as the breast cancer risk assessment program, the upcoming launch of the expanded MyRisk panel. We plan to expand our testing portfolio in other attractive cancer segments, such as therapy selection, including comprehensive genomic profiling and HRD assays, immuno-oncology therapy response monitoring and MRD. As you can see here, these are large, high-growth market segments, and though there are other companies in these areas, we believe we have the opportunity to build meaningful revenue streams here based on health care providers and systems wanting to work with only a handful of specialty diagnostic labs that they trust who can provide multiple tests that they need. And we will leverage the established trust and reach that we have with thousands of relevant health care providers. Strategic partnerships, such as the one we have with PATHOMIQ to enable us to provide prostate cancer tests that combine the power of molecular and AI analysis will help us bring compelling test to market faster. I expect to have more exciting news regarding strategic partnerships to share with you over the coming quarters. Also, as part of this pillar, we will plan to increase our investment in R&D for the CCC and focus on enhancing our commercial capabilities and customer digital experience. On this next slide, let me move to the other 2 strategic pillars. While we are focusing on accelerating growth in the Cancer Care Continuum going forward, our second strategic pillar reflects our recognition of the opportunity to meaningfully grow prenatal health and mental health revenues at or above market growth. We will do this in prenatal health by leveraging recently launched tests, including Prequel NIPS that can be performed 8 weeks into pregnancy and an expanded Foresight carrier screen panel, both of which have been well received in the market. In addition, we recently commenced early access for our FirstGene multiple prenatal screen that we believe has significant potential to expand the prenatal market over time and plan to do a full commercial launch in 2026. We expect to continue to grow revenue for our market-leading mental health test GeneSight by focusing on high-volume accounts and leveraging state biomarker laws, building on the success we've been seeing this past quarter, including a number of payers newly initiating coverage of the test and while we achieved this growth for prenatal and mental health while maintaining a disciplined level of resourcing and investment in these businesses while prioritizing investment in the Cancer Care Continuum strategic pillar. The third strategic pillar is about our focus and commitment to delivering sustained profitable growth. While we will provide further financial detail in the future, we believe execution of this updated strategy will enable us to grow revenue in the high single-digit to low double-digit range and increased profitability over the next 5 years by complementing the revenue growth drivers outlined in the first 2 strategic pillars with increasing focus on maintaining financial discipline, growing revenue faster than operating expenses and strengthening our planning and execution capabilities. We expect to fund near- and longer-term revenue growth, in part, by maintaining industry-leading gross margin profile, which is enabled by low cost per test, leveraging operational excellence and stable pricing, leveraging strong revenue cycle capabilities. Moving now to the next slide. I've already shared when introducing the CCC strategic pillar why we're choosing to focus on cancer and our strength that we believe we can leverage to drive accelerated growth and increase access for patients. I want to take a moment to share what we're going to do differently from before to enable our intended success. First, it's about capital allocation. We're going to be disciplined in prioritizing investments, resources and organizational focus on attractive Cancer Care Continuum opportunity. Next, it's about compelling portfolio. We plan to expand beyond the established tests we have in HCT and HRD to complement them with relevant offerings for other important high-growth testing applications. Next, it's about strategic partnerships. Unlike before, we see an increasing opportunity to serve attractive market opportunities in a timely manner by complementing Myriad's differentiated capabilities by leveraging select partnerships. And finally, it's about execution. We've started to and will think and act with elevated urgency and strengthen execution through enhanced processes, continuing to add the right talent and elevated rigor and discipline. I'm confident that the implementation of our updated growth strategy based on these 3 strategic pillars that I shared with you along with strengthening our organization and execution will enable Myriad to drive sustained profitable growth. Now let me hand it over to our COO, Mark Verratti. Mark?

Thanks, Sam. Turning to the second quarter. I would echo Sam's comments regarding the strong broad-based trend in average revenue per test, which was driven by a combination of test mix, sales targeting, revenue cycle projects and expanding payer coverage. Looking at our businesses. Hereditary cancer revenue grew 5% for the quarter, reflecting 10% volume growth year-over-year in our oncology channel and a modest but improving 3% volume growth in the unaffected population. This is -- this improving volume growth trend in the unaffected market is particularly important as it reflects an improving EMR environment due to focused workflow improvements put in place in our first quarter. Consistent with what we said on our first quarter call, these improvements can take several quarters to produce results, so we are pleased with the Q2 progress and expect continued growth throughout the coming quarters. As we discussed in Q1, we are expanding our breast cancer risk assessment program including a fully automated process that enables providers to rapidly identify patients who qualify for additional screening. We continue to see positive momentum in our initial sites and expect to make further investments in our commercial capabilities to accelerate this program through the second half and into 2026 to fuel growth in our MyRisk volume. Our prenatal performance was mixed in the quarter as revenue grew 7% year-over-year, helped by expanded payer coverage for Foresight expanded carrier screening, but volume growth declined due to temporary interruptions encountered in the transition of our internal prenatal order management system. We have fixed the issue in the second quarter and do not anticipate further disruptions from our system change. Moving to oncology. In the second quarter, total Oncology revenue grew 4% over the second quarter of '24 driven by strong hereditary cancer testing. I would call out that our MyRisk test continues to gain share in the affected market in the second quarter as volume grew 14% year-over-year. Shifting to prostate cancer, Prolaris revenue in the second quarter grew 4% year-over-year, an improvement from the last few quarters. Overall demand remains relatively consistent with 2024 trends and does not appear to have been impacted by the Q4 '24 update to NCCN guidelines. And now that we have announced our partnership with PATHOMIQ, we are excited to incorporate their AI technology platform into our portfolio. With the target of a first quarter '26 launch, Myriad will be the only company to offer AI, biomarker, germline and tumor profile testing. Although our volume has been relatively consistent, we are not pleased with this business performance and feel Prolaris has strong clinical utility and provider support. As mentioned on previous calls, we are investing in the commercial channel and other programs to grow and regain share in this market. I'm also excited to call out, in collaboration with National Cancer Center Hospital East in Japan, new clinical data regarding the use of Myriad's ultrasensitive Precise MRD test was presented at this year's American Society of Clinical Oncology Conference in May. This data showed that 100% baseline sensitivity and that 60% of patients testing positive 1 month after surgery had levels only detectable via our ultrasensitive MRD test. We are excited to commence an early access launch of our ultrasensitive Precise MRD test in the first half of 2026. Moving to our Women's Health business. In the second quarter, Women's Health delivered revenue of $90 million, an increase of 4% over prior year period. As I mentioned earlier, we are pleased to see incremental positive momentum in hereditary cancer testing in unaffected market, with revenue growth of 1% and volume growth of 3% year-over-year. We remain optimistic about our increasing tailwinds from EMR integration and breast cancer risk assessment program implementations. In addition, we are seeing continued positive traction in hereditary cancer testing from our expanded commercial partnerships like jscreen. As for prenatal testing in the second quarter, we encountered modest volume headwinds as we discussed, we fixed the internal issue and anticipated prenatal test volume to accelerate in the second half of the year. As for our commercialized test, Prequel at 8 weeks and Foresight, we continue to see positive demand. And I would call out incremental positive payer coverage for the expanded carrier screening panel ahead of any ACOG guideline update. Lastly, the team is excited about the early access launch of our first gene multiple prenatal screen in June. We believe this test provides added insight to providers and has the potential to expand the overall addressable market. We are looking forward to full commercial launch next year. Turning now to Mental Health. In the second quarter, the team generated GeneSight revenues of $38 million on volume growth of 5% year-over-year, an improvement from our first quarter that was impacted by the realignment of group resources. We continue to drive expansion of the ordering provider base, achieving a record number of ordering clinicians to over 36,000 in the second quarter. While quarterly revenue continues to be impacted by UnitedHealthcare's coverage policy change, we continue to make progress publishing additional data, such as the meta-analysis accepted for publication in the Journal of Clinical Psychopharmacology that follows the economic utility data published in the same journal in Q1. We expect United to review our new clinical data as part of their typical review cycle in the fall. While we continue to work with United to achieve a successful outcome for both parties, we continue to make forward-looking decisions assuming the status quo. We are excited and proud of our payer markets team for securing positive coverage policies for GeneSight in Q1 and Q2 related to biomarker laws. Most recently, the California Medicaid program, Medi-Cal, added GeneSight with a September 25 effective date. Noting, we have not seen any new negative policies this year. I am proud of our GeneSight team that continues to drive growth and focus on the unmet need in mental health care treatment. Building on what Sam shared, our strategy for GeneSight growth includes continuing our highly effective digital engagement from driving provider and patient awareness to provider onboarding. It also includes optimizing patient direct payment options and optimizing revenue cycle workflows to maximize reimbursement. I will now turn the call over to our CFO, Scott Leffler.

Thanks, Mark. I'll start with a recap of our Q2 consolidated financial results. For the second quarter, we reported revenue growth of 1% year-over-year, with test volume down 1% but average revenue per test, up 2%. The improvement in second quarter overall revenue per test reflects a combination of product mix and the expansion of payer coverage for a number of tests. There was no material contribution from prior periods in either the second quarter of 2025 or 2024. Therefore, we have a fairly clean view of underlying organic rate trends, which continue to be very encouraging. While Q2 rates were unfavorably impacted by the change in UnitedHealthcare policy with respect to GeneSight coverage, we continue to see a positive trend in underlying rates across our portfolio. This is a continuation of the generally positive trend we have been reporting for at least a year now and represents another proof point for the great work being done by our revenue cycle and payer markets teams, along with others throughout the company. As we have said before, I want to emphasize the sustainable nature of these improvements, which we believe represent both the great work being done by our team as well as the maturation in the reimbursement landscape for our products. As Mark pointed out, the hereditary cancer testing in the affected population saw the strongest revenue growth in the second quarter, with revenue increasing 9% year-over-year. Our Pharmacogenomics business saw revenue declined 12% year-over-year due to the impact of the UnitedHealthcare coverage decision, but volume growth year-over-year rebounded in Q2 as the team adjusted to reallocated resources. You may recall that we attributed the underperformance in GeneSight volume growth in Q1 to the transition associated with our reorganization of the commercial organization in pharmacogenomics. We had predicted that once the newly organized team had more time to stabilize, we would see a recovery in volume growth trends. The recovery to mid-single digits volume growth for GeneSight in Q2 is a validation of that view. The combination of a reacceleration in GeneSight volumes and unaffected HCT volume represents an important proof point in our efforts to recover from the headwinds we cited in Q1, buoyed by the incremental strength and reimbursements. Even with the modest overall Q2 revenue growth, we were able to expand our gross margins by 140 basis points to 71.5%. This year-over-year improvement reflects favorable test mix, expanding payer coverage and lab efficiencies and is a testament to the power of our scalable business model. Second quarter adjusted operating expenses increased minimally year-over-year and reflects cost controls across SG&A. We continue to focus on striking the right balance between investment for future growth and profitability, with a concerted effort to divert spend to areas consistent with our strategic priorities. While we are pleased with the favorable progress in our overall business results, we did have a significant noncash negative item impacting our GAAP results. Due to the significant and prolonged decline in our market capitalization this year, we recognized impairment charges of $317 million of goodwill and intangibles in the second quarter. This charge is noncash and excluded from non- GAAP EPS. It is important to emphasize that this charge does not represent a meaningful change in our business outlook. We are simply following standard accounting practice, which required that we test the carrying value of our goodwill and intangibles in light of the drop in market cap. Without getting too deep into the mechanics of the process, our testing result was adversely impacted by factors such as much higher assumptions regarding cost of capital in connection with the drop in market cap. So I would characterize the charge as the result of developments that had already occurred earlier in the year as opposed to any deterioration in expectations. Next, I'll speak to the trends supporting overall robustness in revenue per test. For a while now, we have provided details regarding a number of key drivers for sustainable progress in average revenue per test, including various investments and initiatives by both our revenue cycle and payer markets teams. We continue to see positive traction from these ongoing investments in revenue cycle workflows and from our ongoing payer engagement activities. These include, among other things, working with health plans to encourage their implementation of medical policies that conform to state biomarker legislation. As discussed on prior earnings calls, there is a growing list of states that have passed biomarker legislation that lends itself to ensuring access to precision medicine and advanced diagnostics. As we've mentioned, we recently received expanded commercial and Managed Medicaid coverage for GeneSight, and as Mark called out, we are pleased to see California's Medicaid program, Medi- Cal, commencing coverage beginning in September. And there are several other payers who have moved forward with GeneSight coverage. Perhaps the most significant area of progress has been in prenatal testing, where we have seen a significant uptick in payers covering expanded carrier screening, even without an update to ACOG guidelines that has been anticipated for such a long time. We applaud the progressive approach that many payers are now taking to cover ECS testing, and we see this trend continuing to benefit prenatal reimbursement going forward. Year-to-date, our team has won 49 new product coverage or medical policy expansions from payers as we seek to bridge gaps in coverage across our no-pay universe. As I have said in the past, no one of these wins will generally meaningfully move the revenue needle, but we certainly expect the accumulation of many small and medium-sized wins over time to contribute to the maturing and more stable rate environment for our products. Next, we'll take a deeper look at the unusual items impacting our year-over-year revenue trajectory to provide a better sense for performance of the underlying business. While revenue in Q2 of this year compared to Q2 of 2024 grew 1%, you've also heard Sam reference a second quarter 2025 revenue growth rate of 5% after adjusting for the impact of certain items on our Q2 of 2024 baseline, namely, UnitedHealthcare's net impact on GeneSight of $7.1 million and the divestiture of our EndoPredict European business of $2.4 million. With these adjustments, we are able to show what we consider to be a clearer view as to Myriad's underlying performance trends. Next, let's discuss the company's recent capital raise. Last week, we entered into a 5-year term loan with OrbiMed, a well-known health care investor. This agreement provides Myriad an initial tranche of $125 million immediately at a floating rate of 1-month SOFR plus 650 basis points or an annual interest rate of approximately 11% at current rates. The agreement also has a 2-year option to draw on an incremental $75 million of committed financing reaching a potential total loan amount of $200 million. Initial use of proceeds was to replace our existing ABL facility from which we had drawn $60 million as of the end Q2. Including the option to draw on the second tranche of the facility, we have an estimated total potential liquidity of over $200 million. We are thrilled with this financing and consider it to be a significant upgrade from our previous capital structure. While the interest rate on drawn amounts was previously lower, our previous ABL was a short tenor facility with only minimal opportunity for incremental financing given its reliance on accounts receivable balances. Our objective was to obtain a larger amount of financing in order to ensure multiple years of liquidity comfort and the ability to invest as needed in areas of strategic prioritization. This facility provides that. While the rate on the initial tranche is higher than the ABL rate, we are excited to have the second tranche of committed capital at minimal cost. The blended rate we are paying for $200 million of committed capital for both the drawn first tranche and the undrawn second tranche is approximately 7%. Lastly, we generated $14.5 million of adjusted EBITDA in the second quarter, a significant improvement over first quarter. The combination of our strong gross profit base and increasing levels of adjusted EBITDA profitability demonstrate the profit and cash generating potential of the business, especially as we generate more operating leverage over our operating expenses. The fact that we're able to generate such a strong EBITDA quarter, despite the headwinds that we have encountered this year is a testament to the profit generating potential of the business as we reaccelerate growth. Next, I'll cover our full year 2025 guidance. For the full year 2025, we are updating the financial guidance that was previously updated in May. We are raising our full year revenue range to $818 million to $828 million, largely reflecting our positive Q2 revenue performance. We are also increasing our gross margin range to between 69.5% and 70%, and increase in the adjusted OpEx range to between $562 million and $568 million. We are keeping our adjusted EPS between a loss of $0.02 and a gain of $0.02 for full year 2025, reflecting the incremental interest expense associated with the new financing. Lastly, we are also raising adjusted EBITDA to between $27 million and $33 million. We are not providing quarterly guidance. But please recall that the third quarter is seasonally slower than the second quarter. In addition, Q3 of 2024 will be an unusual comp due to a large almost $9 million added period benefit in that quarter, which we do not expect to repeat this year despite the fact that the underlying rate environment remains even stronger in Q3 of this year than it was in Q3 of last year. Now let me turn the call back to Sam.

Thanks, Scott. Overall, Q2 results were positive and demonstrates the profitability potential of our business model. Strength in our core oncology HCT franchise continues and an improving unaffected HCT business reflects progress with the EMR integrations. We think these trends will continue in the second half. Q2 also demonstrates the ongoing execution of our payer markets group, supporting more coverage of our portfolio further supporting overall growth and profitability. The team is also excited to move forward with a clear, focused growth strategy. The priorities that underpin this strategy will go a long way to enhancing our focus and execution rigor across the organization. While we plan to provide additional details in the coming months, our updated strategy better positions Myriad to achieve this mission, advanced health and well-being for all and to positively impact an increasing number of patients while driving accelerated growth and profitability. I'll now pass the call over to Matt for Q&A. Matt?

Thanks, Sam. And as a reminder, during today's call, we use certain non-GAAP financial measures. A reconciliation of the GAAP to non-GAAP financial results and a reconciliation of GAAP to non-GAAP financial guidance can be found in our earnings release and under the Investor Relations section of our website. Now we're ready to begin the Q&A session. [Operator Instructions] Operator, we're now ready to take the Q&A portion of the call.

[Operator Instructions] Our first question comes from the line of Doug Schenkel from Wolfe Research.

I really want to focus a couple on the strategic review. I appreciate all the qualitative details. I do think it would be great if there were more specific KPIs that we could use to measure progress, both in terms of the near term and the long term. Is the intent of this update today to demonstrate, hey, we're making progress. We're working on this but to basically make the point that the KPIs are coming soon? So that's the first question. The second is the language you're using seems to suggest that you've completed the strategic review of the portfolio. So should we essentially believe at this point, there's not divestitures coming, you are happy with the portfolio plus the pipeline as currently built? And then last one, I will get back in the queue after this. A lot of what you described makes sense. I would also say like a lot of it sounds pretty unobjectionable, and I would imagine that would also be the case with some of your predecessors. They also wanted to grow more than the market. They also wanted to grow revenue more than OpEx, things like that, that make a lot of sense but are objectionable. What is the biggest thing that's changing here relative to previous administrations?

Doug, thank you very much for the questions. I appreciate it. You're spot on. Absolutely, this was intended to share where we are with the strategic review, the clarity on the pillars, what we're going to do and that over a 5-year horizon that we believe the execution on these things will drive accelerated profitable growth, high single digit to low double digit. And yes, we will both be measured, and we look forward to sharing details on KPIs and more specific details, as you said, in a more quantifiable way in the upcoming months at maybe JPMorgan, but that's additional work that we're continuing to do. I think your second question was related to are we happy with the portfolio, how do we think about divestitures? I mean, again, the work that we did gives us some real excitement about the strategy and being able to implement it to drive this accelerated growth. And as part of running the company, with increased rigor and discipline, we're going to periodically review all product lines, including GeneSight to determine the ability to really support those strategic goals, right? So that's the -- we'll be approaching it. And third, about -- thank you for viewing what we shared today as non-objectionable. I think I'll take that as an endorsement, but very good point about what does this mean and what's going to be different. Listen, there's [indiscernible] along with really focusing on high-growth market segments. Our franchise in oncology has been an important one and a good one, but it has been primarily hereditary cancer testing and HRD. It's expanding beyond that into these other high-growth applications and being able to do that by -- it's not all Myriad, through partnerships is an important change. Another important change is our stepped up urgency, our rigor and discipline and how we're going to execute and just really make it a high-functioning, high-execution company. And those are the things, together with adding the right team that really understand the space and the domain, I think is going to be the difference for really being able to deliver on the intent of our new strategy.

Our next question comes from the line of Puneet Souda from Leerink Partners.

So obviously, GeneSight was clearly an important product, a flagship product for you, impacted here by the United coverage. I know you talked about the feedback that you expect in fall. But can you maybe talk about what has been submitted to United? Any of the early conversations giving you any leads in terms of when this can actually be resolved or not resolved? I mean, just maybe just help us understand what should we -- what should our expectations be. And just wondering any of the other commercial payers, are you getting any requests for further reconsiderations from other payers? And I have a follow-up.

Yes. Let me thank you, Puneet. I appreciate the question. I'll start, and then I'll hand it to Mark to add additional details. So again, we are happy that we've been able to, through the actions we've deliberately taken, increase the growth of GeneSight back to where we expected it to be by year-end, which is mid-single digits. And kudos to the team for the refocus, the execution, and our rev cycle team and payer markets team, which continue to really drive opportunities with new payers. And then I'd hand it off to Mark about timing and other things that you're asking. Nothing's changed on that, but I'll let Mark detail what we've shared in the past in terms of time points, what we're doing. Again, to dispel this point, we haven't traditionally had a lot of commercial payers that we have agreements in place with. And no, we haven't experienced that. Quite to the opposite, as you heard, I think, in Scott's prepared remarks, we're actually seeing a number of new carriers that are joining. So Mark?

Yes. Thanks, Sam. So Puneet, just to give a little color to Sam's last comment, which I think we stated, right? We've had several wins across different commercial payers, mostly related to biomarker laws both in Q1 and in Q2. So we are seeing positive movement there for GeneSight, and it's across some commercial plans as well as Managed Medicaid and of course, Med Advantage plans as well. Related to United, which we also said on the call, we plan on submitting 3 publications as part of United's typical review cycle, which takes place in the fall. Two have already been published both in the Journal of Clinical Psychopharmacology. One was an economic utility study that we did with Optum. The other one is a new meta-analysis focusing on the randomized trials related to GeneSight, and a third is a sub-analysis related to the large prime care randomized trial that was done through the VA. So we plan on submitting those in the fall. We would expect United to review those as part of the typical review process. So we would expect to hear either status quo or potentially a change in that policy. November, December time frame, which is when they usually announce, and the effective date would be the beginning of 2026.

Got it. That's very helpful. And then on MRD, could you confirm the timing of the launch has moved from first half '26 full launch to an early access launch? I wasn't clear what I heard on that, so maybe if you can clarify. And what -- we saw obviously sort of your ASCO data. Just wanted to understand, what remains to be done the validation studies? Any other studies that we should be expecting on MRD before you get into that early access phase?

Yes. I mean just -- thank you for that question. We're continuing to make good progress on our MRD clinical studies that are underway, upwards of 20 that we're working on. And by year-end, we expect to have more clinical utility work that's done and to submit for MolDX sometime in Q1, expecting MolDX, if they're with customary time lines, approval sometime towards the end of the year. We will -- however, we're making a strategic decision because we think it's important to get our test in the market, so important providers can start using it to really -- in the course of treatment of patients, we intend to do that in the first half. And so we'll be strategic and taking that out in advance, what is likely to be in advance of receiving MolDX. And because we're not going to do a broad, full commercial launch to everyone, that's why you might have heard us use the term early access, meaning focus still on quite a number we haven't determined yet of actual providers using it in the course of medical care.

Our next question comes from the line of Dan Brennan from TD Cowen.

This is Kyle on for Dan. I wanted to go back to the sort of mid- to longer-term guide here of high single digits to low double digits, not too far off from where you were before, 12% plus. But maybe can you just walk us through what the puts and takes there are across the portfolio just given that you'll be layering in some new tests with MRD, et cetera? How should we think about the different segments in the context of your guide?

Yes, maybe I'll start here. And Scott, you can add in. And Kyle, thanks for the question. And our intention is to share more details, more quantifiable numbers and KPIs, including more specifics around our growth rates over the coming months, including in the JPMorgan. But what you can tell even from the strategy, the way that we shared it, is if you look at our second pillar, which is about prenatal health and mental health, being able to grow at or above market, right, we know that the prenatal market is growing somewhere in the low to mid-single digits. And we believe we're going to be able to grow that faster based on again, the recent products we've launched and the excitement that we have for FirstGene, the new product that we have. And GeneSight for mental health, we've already resumed growth back in the mid-single digits, and we are the market leaders there. We believe we can do that. It's really in oncology where we are seeing, again, really good growth in hereditary cancer. We have big markets here. We believe the combination of growing ourselves in the high single digits to low double digits in hereditary cancer testing, both across the combination affected/unaffected, but then when you look at these new areas, which is an important net new, right, important part that we're trying to share and the strategy is our intention through both the work we're doing, like, for example, an MRD, but through partnerships to enter into these other important segments, if you will, including IO therapy response monitoring, more on comprehensive genomic profiling. These things will -- our products that we bring to market there ourselves or through partnerships really should grow in the -- at least in the low double digits. So it's that composite when you put it together, including prostate cancer. By the way, we're excited, again, about the partnership with PATHOMIQ and on track to launch that combined product, our first combined product in Q1. So all of these things, hopefully, Kyle, give you a little bit of color on how we can -- we have confidence to grow high single digit to low double digit. Scott, would you add -- I was pretty comprehensive there.

Yes, I don't have any more details on the financial targets at this time, but I'll just reiterate Sam's comment that we weren't necessarily intending to provide a formal and fulsome update to our LRP right now. That will come at a later date perhaps by the end of the year or the very beginning of next year.

Our next question comes from the line of [ Yuko Oku ] from Morgan Stanley.

This is [ Jason ] on for [ Yuko ]. Congratulations on the quarter. Maybe just a question on Prequel. I'm wondering how has traction for the test been since the launch in 4Q of last year? Has it been ahead of expectations or in line? And given the test differentiated 8 weeks gestation age approach, have you seen any share gains from other players in the space?

[ Jason ], thank you very much for the question. Mark, why don't you take this one on Prequel and how its traction in the interest of the 8-week gestation?

Look, I think as we've said before, we're excited about the launch, and we've seen tremendous uptake mostly because as we stated at that 8-week time frame is typically when that is the first prenatal visit. And so it fits very nicely within workflows. So we have seen an uptick. We have seen volume increase there related to the test being ordered earlier, which is great. As far as our ability to be able to tease out the differentiation of stealing share, I think that's been a little bit more challenging. But as Sam mentioned, as we see growth there, we'll try to highlight that moving forward.

Our next question comes from the line of David Westenberg from Piper Sandler.

Congrats on the quarter. Sorry if I'm asking repeat questions. I've been hopping in between some queues here. So I just want to ask on the prenatal. You mentioned the friction from the new management ordering system. Can you quantify that impact and -- if you didn't already, and then steps to resolve it and how soon it can be resolved? And then just generally speaking, if you -- just want to make sure that when this thing kind of thing happens that it's not a switch in provider. And can you give us a comfort on that?

Yes, I'll start, and I'll hand it over to Mark. Dave, thank you for the question. I just want to clarify, be very clear, that's a redundancy there. The problem was related to an order management system. It has been addressed. So it's not like we -- we not only had a beat on it, but we have resolved it. But Mark, there's other parts of the question like -- yes.

Yes. I think the other parts of the question. So again, we have resolved it, so we don't expect it to continue at least from a system error perspective to continue into Q3. From a provider perspective, look, many of our accounts use multiple providers, and so we see shifts throughout the quarter. So I don't know if we can quantify it. I think our results this quarter and our excitement about prenatal products growing in the back half of the year pretty much reflect the way we feel about resolving the issue and about the strength of Prequel, as the previous caller asked around Prequel at 8 weeks as well as the strength in our Foresight product as well. So...

I'll just add to that. This is Scott. If you look at overall prenatal volumes, at least on a year-to-date basis, they're down about 4%. And so that is -- it's something that obviously is very different from what we normally expect in that line of business or that product category, we would expect something in the high single digits to low double digits. And so that impact you can attribute to the disruption.

Our next question comes from the line of Tycho Peterson from Jefferies.

I want to probe into the guidance raise. Obviously, you lowered last quarter, now you're raising. Maybe just for the back half of the year, how much is hereditary? Just talk about where the incremental step-up is. Also OpEx is going up. Curious about that given some of the cost-out initiatives. And then I did want to probe on the LRP. I know you got the question earlier. But did anything change in kind of your end market growth assumptions relative to last fall?

We'll go backwards. Tycho, thank you for the question. In terms of your last question, no, nothing material. So it's not because we just -- we're benefiting from a new increase of a market or anything like that. That's not it at all. It's again about, as I answered, being able to participate in a meaningful way in other segments of Oncology or the Cancer Care Continuum, which we're not today and strengthening our own products, too, right? So those are the drivers there. Scott, before I hand it over to you to answer a little bit more here, I'll say again that what has happened here in this quarter is we identified very clearly the challenges and the issues that were some of our biggest challenges in Q1. Again, we talked about changes we've made and the impact that it had related to GeneSight. We talked about unaffected hereditary cancer and workflow-related issues, including EMR. So we have been incredibly focused and the team has been working hard. And again, as I mentioned, I'm pleased that we've been able to execute and some of the results are exactly what we expected by the year-end. So this is not by chance or not by luck. We have done the work to make it happen, but it's been a little bit faster than we expect. But I don't know, Scott, if you want to -- there was a quantification question to hereditary cancer.

Sure. Thanks, Sam. And we don't guide at the quarterly basis nor do we guide at the individual product basis. But what we have talked about already, even on the last earnings call was around the expectation of sequential improvement throughout the year in the areas that have been adversely impacted by some of these kind of headline headwinds that we've referenced. And so when you think about the hereditary cancer testing unaffected journey that was one of the headwind items that we had flagged on our last earnings call where, as Sam was referencing, really excited about the incremental progress that we've made in accelerating volume growth in Q2, but that's not yet where we want it to be or expect it to be. And so that is one of the areas where you'd expect to see or we expect to see a further acceleration in the second half of the year. Similarly, the prenatal challenges that we're kind of newly referencing now, we certainly expect to significantly rectify in the second half of the year. One of the other areas that we referenced on the last earnings call was the near-term headwind in terms of GeneSight volumes primarily associated with the transition in the commercial organization there. We're pretty excited to have quickly recovered the volume trajectory there, at least within striking distance of where we expect it to land longer term. But those are the areas that we expect to see improvement and to deliver the guide for the second half of the year.

Our next question comes from the line of Bill Bonello from Craig-Hallum.

I guess I have a couple of follow-up questions going back on the strategic plan. I'm just trying to wrap my arms a little bit more around the oncology strategy. I mean I think I get it, you're saying you're going to add a bunch of additional products to try and grow in that channel, and you may do that on your own, you may do that through partnership. But maybe just talk to us a little bit about sort of your right to play in that market. What is it about your position in hereditary cancer that sets you up to have success in the other areas of oncology testing and help us think about how you might compete relative to the oncology testing companies that are already out there with multiple therapy selection tests and MRD, et cetera? And I have one follow-up.

Yes. Thank you very much for the question, Bill. I appreciate it. And it's very important. Listen, what we believe we bring that's differentiating that we're going to be able to leverage include, like you said, because of our hereditary cancer leadership, being the gold standard in the market with that as well as HRD, we have a reputation. We have a lot of trust. We also have access into thousands of the most relevant health care providers and systems. We also hear loud and clear through our primary and secondary research that increasingly health care systems and providers really want to down select to just a handful of providers that can provide them the most critical test along the cancer care journey for a patient. So it's our ability, once we're there, we know that if we're able to provide other tests that are meaningful, that are easy to use and access that we have a right, along with the fact that we have heard, and this is something that we already have strength in is being able to provide a unified report, which makes it easier to interpret from multiple tests that is to help, particularly when you're thinking about a molecular tumor board, then you have that information that accelerates decision-making. So it's those things along with adding to our portfolio and focusing in where our strength is, right? We are going to focus in, for example, on MRD where we know our ultrasensitive differentiated assay makes a difference to look at these low shedding tumors, and we're going to focus in on breast because that's one place, and we all have an established reach, reputation and trust with that community.

Our next question comes from the line of Subbu Nambi from Guggenheim Securities.

This is Ricki on for Subbu. You got a few on women's health already, but wanted to see how the ramp for SneakPeek has been going so far and it's near almost a year on the market. And if you've seen the goal about funneling patients from SneakPeek to Prequel starting to materialize yet. And then also just wanted to revisit the strategic update here in the context of women's health and mental health. Could you just provide some more color on what's new here incrementally like compared to prior comments in the last Investor Day?

Yes. Maybe I'll take this and Mark or Scott, if you want to add in, please do. But I mean listen, our SneakPeek business is one that strategic intent was really to complement, get in early on the cycle of engaging with a woman in her overall pregnancy journey. Quite honestly, it's been a challenge for us. And it's been an area that we still believe has a lot of potential, but given the areas we're focusing on, it hasn't been something we've spent a lot of time in the immediate time trying to optimize. So more on that as we have a chance to go into the next level of our own planning on our strategy. Your second question is like what's net new? It's a great question. Again, so let me just be very clear. For prenatal health, we believe that the recently launched products, it's not just the NIPS Prequel at 8 weeks gestation age. It's also the expansion we had to our Foresight expanded carrier screening assay as well as now the early access, which we launched in June for FirstGene, which is the combined screen, right, which brings the benefit of both NIPS together with carrier screening. Those things, we believe, will allow us to differentiate and grow at or above market. And on mental health, again, it's really a focus in on being able to execute with more precision on targeted accounts and continue to drive improvement in our overall payer markets and revenue cycle activities. One huge, huge, huge important difference from before is our absolute commitment to be deliberate in the level of resourcing focus and investment we will put into these businesses. It's going to be in a very focused, targeted way because our intention is to really focus in and grow the Cancer Care Continuum business. That's the difference.

Our next question comes from the line of Sung Ji Nam from Scotiabank.

Just will ask one in the interest of time. I was curious in terms of your expectations for above-market growth going forward. How much of it is, do you think, coming -- will come from taking share away from others, your competitors versus you guys more efficiently penetrating into the kind of the underpenetrated segments of the market? Just given that there is significant deployment of EMR and things like that across the industry, I was just kind of curious how realistic it is -- is actual share gains in a more competitive market environment.

Yes, Sung Ji Nam, thank you very much for the question. And I think the short answer is both, right? We are excited to be particularly around the Cancer Care Continuum. We are participating in large, attractive high-growth markets. So the numbers we've shared overall, the 5-year high single digit, low double digit is enabled by growing with the market there in those components. We intend to do better. So -- and that -- how we will do better is, again, the combination of our tests where we can really win an account and provide value by having really compelling tests that come together in a report that makes it easier because it is true. Over time, the differentiation of a lot of the tests are waning, not always the case, right? Again, in MRD, we believe we have a truly differentiated opportunity with the very low parts per million detection capability that we have. And then in GeneSight, we're going to grow essentially with the market because we are the market leaders, very strong market position. Prenatal, we think we have an opportunity to grow. We absolutely do. The market is growing low to mid-single digits. We intend to do better than that once again because of those differentiated products we've launched recently and other ones we're going to do. Not to mention, Brian Donnelly has joined the team as our new Chief Commercial Officer, and a new perspective on stepped-up commercial execution that I think will complement the great work that Mark did beforehand.

Our next question comes from the line of Brandon Couillard from Wells Fargo.

Sam, at a high level, you talked about one of the increased R&D investment to support the cancer strategy. Can you do that within the current R&D investment run rate? How much is currently allocated to oncology? And how much incremental spend should we kind of anticipate there in the next few years?

Yes. Great question. Thank you for that. Like we mentioned earlier, we're not providing specifics on financials now, but we intend to be -- provide more as we -- as the months come, particularly heading into JPMorgan. But yes, to answer your question, we believe, through deliberate management of where we spend our R&D dollars, that we are -- and growing R&D, right, this is based on -- another thing you heard me say in the comments is we will grow revenue faster than operating expenses. So still being very disciplined in how we do that overall. So the P&L profile of the company continues to strengthen over this 5-year period, but we believe we can increase our investments in R&D and oncology in a meaningful way to achieve our objectives. And again, we will get the benefit. We don't have to develop it all ourselves. Some of it will come through partnerships that enable us to get to market faster with a differential cost profile as well.

Our next question comes from the line of Michael Ryskin from Bank of America.

Great. A lot has been asked already. I just want to squeeze one more in on some of the strategic pillars you talked about. You kind of talked about strategic partnerships a little bit more for some of these newer parts of the Cancer Care Continuum. Can you just give us a couple of examples of what that could look like, both from a -- what type of partner you'd be looking for, how that would develop? I realize this is sort of really far in the future, but just theoretically, how we should think about that and what the financial profile of that might look like, that would be helpful.

Michael, thanks for the question. And hopefully, it's not so far in the future that it's a long time for now. I think the PATHOMIQ relationship that we have for being able to leverage the AI capabilities that PATHOMIQ brings together with our molecular assay for prostate cancer, Prolaris, is an example. What we're doing in at least some of the partnerships we're considering is where we call -- the R&D or the product development capabilities of a partner will be complemented by our reach into the market, our reputation, our ability to really do all the way from ordering through delivery and support. And you can imagine that these relationships can be set up in a way where there are milestone payments and royalties to go along with it but in a way that we think that we can achieve shared objectives, in a way that's also favorable to Myriad's overall financials.

Our next question comes from the line of Mason Carrico from Stephens Inc.

Sorry if I missed this, but I did not hear any commentary around Precise Liquid. So could you give us an update on where that product stands and the launch time there? And then sorry to do this, but going back to the LRP, you guys have been making progress on RCM. You called out 49 new coverage policies or expansions year-to-date. Even qualitatively, I know you may not want to talk directly to the growth rates. But how should we be thinking about the mix of ASP gains and volume growth that's kind of built in there?

Scott, I'll let you take the second one. As it relates to Precise Liquid -- thank you for the question, by the way. We're making a strategic decision that we're likely not going to launch a Precise Liquid product that is based on the assets, if you will, that we acquired last year. Rather, we are excited about being able to serve the liquid biopsy comprehensive genomic profiling opportunity through a partnership. So those will be some of the things that we look forward to being able to share with our customers and all of you in the coming quarters. And Scott, please comment on the second question.

Yes. So in terms of the question around kind of the composition of the LRP, I think what we have communicated in the past was that we thought based on the significant no-pay opportunity that we still have, even after all of the great progress by our rev cycle and payer markets team that we thought we could continue to contribute 100 to 200 basis points per year from rev cycle and payer markets initiatives. Even with the strength that we are seeing this year, and we are very excited about it, particularly when it comes to kind of the progressive position many payers and LBMs also are taking in terms of coverage for expanded carrier screening, even with that, I don't think we'd be ready yet to move off of that longer-term expectation around 100 to 200 basis points.

At this time, I would now like to turn the conference back over to Matt Scalo for closing remarks.

All right. Thanks, Gigi, and this concludes our earnings call. A replay will be available via webcast on our website for 1 week. Thank you again for participating and have a good rest of the afternoon.